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IRCT2017051333941N1 IRCT 2017-06-06 Kashan University of Medical Sciences Effect of supplementation in treatment of Coronary Heart Disease Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus 2017-05-18 anticipated 60 Complete https://irct.ir/trial/26043 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 2 Coronary Heart Disease. Intervention 1: Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Subjects aged 50-85 years; diagnosed with type 2 diabetes, CHD and overweight. 50 years 85 years Both Exclusion criteria: Consuming melatonin supplements within the last 3 months Having an acute myocardial infarction and cardiac surgery within the past 3 months The night shift workers I25.9 Chronic ischaemic heart disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Protein carbonyl. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Systolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer. Diastolic blood pressure. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Manometer. Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Kashan University of Medical Sciences Approved 2017-05-17 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)